Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

POSITION PURPOSE / RESPONSIBILITIES

Under the direction of the Department Supervisor, the incumbent performs the activities listed below, for which they have been qualified through the required training, in compliance with company SOPs, current cGMP requirements, and EHS regulations.

KEY RESPONSIBILITIES

• Ensure the accurate execution and review of Sterile Manufacturing executed Batch Records (eBRs) in accordance with current SOPs, cGMP requirements, and EHS standards.
• Verify the correct completion of batch records, work instructions, checklists, and general production documentation.
• Ensure that all documentation is completed accurately and in full compliance with ALCOA and Data Integrity (DI) principles.
• Ensure adherence to the batch release schedule by delivering completed eBR documentation to the Quality Operations (QO) department within the required timelines.
• Support production schedule adherence by ensuring the availability and proper management of consumables and manufacturing materials (consumption, returns, and material requests) through SAP and Paletti systems. Troubleshoot and resolve issues related to material transactions when required.
• Identify and report discrepancies or non-conformities within manufacturing documentation.
• Notify the Supervisor/Shift Lead and Quality Operations of any deviations or abnormalities identified during production activities or documentation review.
• Support the training and qualification of production personnel in compliance with cGMP requirements and company quality standards.
• Collaborate with cross-functional teams, including Validation, Maintenance, PDS Manufacturing Sciences, Project Management, Quality Operations (QO), and Quality Operations for Facilities (QoF), to support activities within the Sterile Manufacturing Department.
• Initiate process deviations through the TrackWise system when required and support Quality Operations in the management of deviations, investigations, complaints, and the implementation of Corrective and Preventive Actions (CAPAs).
• Collaborate in the preparation, revision, and implementation of Standard Operating Procedures (SOPs), ensuring their effective operational application.
• Maintain and update Production Visual Management Boards to monitor operational efficiency and Key Performance Indicators (KPIs).
• Archive production documentation and verify its completeness and compliance.
• Propose continuous improvement initiatives aimed at reducing operating costs, increasing departmental efficiency, and supporting Operational Excellence objectives.
• Print batch records, manufacturing documentation, and routine production documents required for daily manufacturing activities.
• Support production operators in collecting release samples intended for internal laboratories, external laboratories, and customers.
• Coordinate shipment of customer samples in collaboration with the PDS Logistics and Warehouse teams.

QUALIFICATIONS

Essential Qualifications

Education

• High school diploma or higher educational qualification.

Technical Knowledge

• Knowledge of current Good Manufacturing Practices (cGMP).
• Proficiency with Microsoft Office applications and inventory/material management systems.
• Basic understanding of administrative processes.

Competencies

• Flexibility and ability to effectively prioritize activities.
• Strong interpersonal and communication skills with the ability to interact effectively at all levels of the organization.

Preferred Qualifications

• Previous experience in pharmaceutical or chemical manufacturing operations in a GMP-regulated environment.

What We Offer:

Compensation
Competitive Pay
Performance Related Bonus where eligible
Annual merit performance-based increase

Excellent Benefits
Medical benefits
Paid Time Off/Annual Leave
Employee Referral Bonus
Career Advancement Opportunities